Atazanavir Dosage Form and Label Changes

The FDA has approved a new pediatric dosage form and label changes for atazanavir. Please see the FDA announcement for more information.

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Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

Conduct testing with HIV tropism assay (see Antiretroviral Drug-Resistance Testing in the main body of the guidelines) before using MVC to exclude the presence of CXCR4-using or mixed/dual-tropic HIV. Use maraviroc in patients with only CCR5-tropic virus. Do not use if CXCR4 or mixed/dual-tropic HIV is present.

Maraviroc can be given without regard to food.

Instruct patients on how to recognize symptoms of allergic reactions or hepatitis.

Use caution when administering maraviroc to patients with underlying cardiac disease.

Metabolism

Cytochrome P450 3A4 (CYP3A4) substrate

Dosing of maraviroc in patients with hepatic impairment: Use caution when administering maraviroc to patients with hepatic impairment. Because maraviroc is metabolized by the liver, concentrations in patients with hepatic impairment may be increased.

Do not use maraviroc in patients with creatinine clearance <30 mL/min who are receiving potent CYP3A4 inhibitors or inducers.

Dosing of maraviroc in patients with renal impairment: Refer to the manufacturer’s prescribing information.

Less common (more severe): Hepatotoxicity that may be preceded by evidence of a systemic allergic reaction (such as pruritic rash, eosinophilia or elevated immunoglobulin) has been reported. Serious adverse events occurred in less than 2% of maraviroc-treated adult patients and included cardiovascular abnormalities (e.g., angina, heart failure, myocardial infarction), hepatic cirrhosis or failure, cholestatic jaundice, viral meningitis, pneumonia, myositis, osteonecrosis, and rhabdomyolysis.

The pharmacokinetics (PK), safety, and efficacy of maraviroc in patients aged <16 years have not been established. A dose-finding and efficacy study is under way in children aged 2 to 17 years.1,2 In this trial, maraviroc dose is based upon body surface area and the presence or absence of a potent CYP3A4 inhibitor in the background regimen. Preliminary PK data are encouraging in those on a potent CYP3A4 inhibitor, but low exposures were seen in those not on a potent CYP3A4 inhibitor. Enrollment of and follow up with participants in this trial continues.